Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and Ph.D. in Pharmacology/Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-seven-year-old consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical companies in the US and 50 overseas in 29 countries). Prior to this, he served in director-level and above positions at Searle, Synergen and Beckton Dickinson. He has published 50 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 42 years of broad-based experience in regulatory toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment, and genotoxicology. He is a past president of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections. He has direct involvement in the preparation of INDs (118 successfully to date), NDA, PLA, ANDA, 501(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs, and served as the COO of two pharmaceutical companies while a consultant. He has consulted for FDA, EPA, and NIH, has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 29 years. Dr. Gad is also a retired Navy officer with more than 26 years in service.

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• PrefaceEditorContributorsChapter 1 Introduction: The Gastrointestinal (GI) Tract as a Barrier and as an Absorptive and Metabolic OrganShayne C. GadChapter 2 Methods for the Analysis of Gastrointestinal FunctionRobin C. GuyChapter 3 Safety Pharmacology and the GI TractHenry I. JacobyChapter 4 Gastrointestinal Tract Development and Its Importance in ToxicologyAlma M. Feldpausch, Joseph V. Rodricks, Rosalind A. Schoof and Brittany A. WeldonChapter 5 Gastrointestinal Tract as a Major Route of Pharmaceutical AdministrationRobert W. Kapp, Jr.Chapter 6 Gastrointestinal Function and Toxicology in CaninesCharles B. SpainhourChapter 7 Gastrointestinal Function and Toxicology in MinipigsMaria R. Jones and Alain Stricker-Krongrad Chapter 8 Absorption of Macromolecules by Mammalian Intestinal EpitheliumShayne C. GadChapter 9 Peyer’s Patch Epithelium: An Imperfect Barrier and Effect of the MicrobiomeGary R. Burleson and Florence G. BurlesonChapter 10 Alteration of Intestinal Function by Xenobiotic Exposure: Animal ModelsShayne C. GadChapter 11 The Role of the Microbiome on Metabolism, Absorption, and Toxicity of Xenobiotics in the Gastrointestinal TractShayne C. GadChapter 12 Normal and Abnormal Intestinal Absorption by HumansDavid W. Hobson and Valerie L. Hobson BalldinChapter 13 Classes of Compounds with GI Tract ToxicityAmy L. Mihalchik and Erica N. RogersChapter 14 Species Differences in GI ToxicityShayne C. GadChapter 15 Nanoparticles in the Gastrointestinal TractDavid W. Hobson and Valerie L. Hobson BalldinIndex

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and Ph.D. in Pharmacology/Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-seven-year-old consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical companies in the US and 50 overseas in 29 countries). Prior to this, he served in director-level and above positions at Searle, Synergen and Beckton Dickinson. He has published 50 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 42 years of broad-based experience in regulatory toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment, and genotoxicology. He is a past president of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections. He has direct involvement in the preparation of INDs (118 successfully to date), NDA, PLA, ANDA, 501(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs, and served as the COO of two pharmaceutical companies while a consultant. He has consulted for FDA, EPA, and NIH, has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 29 years. Dr. Gad is also a retired Navy officer with more than 26 years in service.

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• PrefaceEditorContributorsChapter 1 Introduction: The Gastrointestinal (GI) Tract as a Barrier and as an Absorptive and Metabolic OrganShayne C. GadChapter 2 Methods for the Analysis of Gastrointestinal FunctionRobin C. GuyChapter 3 Safety Pharmacology and the GI TractHenry I. JacobyChapter 4 Gastrointestinal Tract Development and Its Importance in ToxicologyAlma M. Feldpausch, Joseph V. Rodricks, Rosalind A. Schoof and Brittany A. WeldonChapter 5 Gastrointestinal Tract as a Major Route of Pharmaceutical AdministrationRobert W. Kapp, Jr.Chapter 6 Gastrointestinal Function and Toxicology in CaninesCharles B. SpainhourChapter 7 Gastrointestinal Function and Toxicology in MinipigsMaria R. Jones and Alain Stricker-Krongrad Chapter 8 Absorption of Macromolecules by Mammalian Intestinal EpitheliumShayne C. GadChapter 9 Peyer’s Patch Epithelium: An Imperfect Barrier and Effect of the MicrobiomeGary R. Burleson and Florence G. BurlesonChapter 10 Alteration of Intestinal Function by Xenobiotic Exposure: Animal ModelsShayne C. GadChapter 11 The Role of the Microbiome on Metabolism, Absorption, and Toxicity of Xenobiotics in the Gastrointestinal TractShayne C. GadChapter 12 Normal and Abnormal Intestinal Absorption by HumansDavid W. Hobson and Valerie L. Hobson BalldinChapter 13 Classes of Compounds with GI Tract ToxicityAmy L. Mihalchik and Erica N. RogersChapter 14 Species Differences in GI ToxicityShayne C. GadChapter 15 Nanoparticles in the Gastrointestinal TractDavid W. Hobson and Valerie L. Hobson BalldinIndex

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and Ph.D. in Pharmacology/Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-seven-year-old consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical companies in the US and 50 overseas in 29 countries). Prior to this, he served in director-level and above positions at Searle, Synergen and Beckton Dickinson. He has published 50 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 42 years of broad-based experience in regulatory toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment, and genotoxicology. He is a past president of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections. He has direct involvement in the preparation of INDs (118 successfully to date), NDA, PLA, ANDA, 501(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs, and served as the COO of two pharmaceutical companies while a consultant. He has consulted for FDA, EPA, and NIH, has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 29 years. Dr. Gad is also a retired Navy officer with more than 26 years in service.

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• PrefaceEditorContributorsChapter 1 Introduction: The Gastrointestinal (GI) Tract as a Barrier and as an Absorptive and Metabolic OrganShayne C. GadChapter 2 Methods for the Analysis of Gastrointestinal FunctionRobin C. GuyChapter 3 Safety Pharmacology and the GI TractHenry I. JacobyChapter 4 Gastrointestinal Tract Development and Its Importance in ToxicologyAlma M. Feldpausch, Joseph V. Rodricks, Rosalind A. Schoof and Brittany A. WeldonChapter 5 Gastrointestinal Tract as a Major Route of Pharmaceutical AdministrationRobert W. Kapp, Jr.Chapter 6 Gastrointestinal Function and Toxicology in CaninesCharles B. SpainhourChapter 7 Gastrointestinal Function and Toxicology in MinipigsMaria R. Jones and Alain Stricker-Krongrad Chapter 8 Absorption of Macromolecules by Mammalian Intestinal EpitheliumShayne C. GadChapter 9 Peyer’s Patch Epithelium: An Imperfect Barrier and Effect of the MicrobiomeGary R. Burleson and Florence G. BurlesonChapter 10 Alteration of Intestinal Function by Xenobiotic Exposure: Animal ModelsShayne C. GadChapter 11 The Role of the Microbiome on Metabolism, Absorption, and Toxicity of Xenobiotics in the Gastrointestinal TractShayne C. GadChapter 12 Normal and Abnormal Intestinal Absorption by HumansDavid W. Hobson and Valerie L. Hobson BalldinChapter 13 Classes of Compounds with GI Tract ToxicityAmy L. Mihalchik and Erica N. RogersChapter 14 Species Differences in GI ToxicityShayne C. GadChapter 15 Nanoparticles in the Gastrointestinal TractDavid W. Hobson and Valerie L. Hobson BalldinIndex